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Is FDA's MedWatch Enough?
–USA Today, 1-12-00
MedWatch is the Safety Information and Adverse Event Reporting Program. MedWatch conducts what is classified as "passive surveillance" meaning it relies on doctors, dentists, nurses, pharmacists, and other health professionals to pass on to the FDA details of serious adverse reactions. While MedWatch has been considered the best voluntary system in the world it still does not appear to be enough. Raymond Woosley, a professor of pharmacology at Georgetown University in Washington D.C., thinks that to look at France in comparison to the U.S. shows that improvements can definitely be made. Woosley says, "In France, they have 30 centers around the country with people trained to look for adverse drug effects. They go into hospitals, look at charts, talk to patients, talk to doctors, fill out forms and enter them in a database. We don't have one site like that." With studies finding that 20% of new drugs will be issued drug recalls or be required to include additional safety warnings over a 25-year period, the FDA will need to make changes in the future.
FDA updating rules for safe drug manufacturing
–August 21, 2002
For the first time in 25 years, the FDA is preparing to revamp rules for safe drug manufacturing due to drug companies pushing for automated pill production and the decreased ability for the FDA to inspect factories. Last year the FDA inspected 1,600 factories for compliance with manufacturing standards, a large decline from 4,300 in 1980. Large factories have not been meeting current standards for quality manufacturing, and recently the FDA ordered a human soft tissue recall. Due to the company's inability to guarantee the grafts were free of bacterial contamination, Schering-Plough agreed to pay a $500 million fine for quality control violations. Eli Lilly may have as many as five drugs under review delayed due to factory problems. The FDA thinks the changes would update the way the agency inspected medical factories as well as allow drug makers to make better use of new technology that could result in better quality. Drug makers told FDA officials that they found the government's rules too hard to adopt without compromising the promise of technological opportunities.
